Clinical trial · Interventional
Lifestyle Intervention to Improve Insulin Sensitivity and Markers of Cardiovascular Risk in Prostate Cancer Survivors
NCT00738140CI-TRIAL-00011335completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to discover if intensive lifestyle changes (such as diet and increased physical activity) improve the body's sensitivity to insulin, and therefore help prevent diabetes and other cardiovascular disease, in men receiving GnRH hormone therapy for prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diabetes Prevention Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- Intensive lifestyle intervention based on the Diabetes Prevention Program
- interventionNames
- Behavioral: Diabetes Prevention Program
- type
- NO_INTERVENTION
- label
- B
- description
- Will follow the guidelines for healthy living established by the Food Guide Pyramid and the National Cholesterol Education Program
Primary outcomes (1)
- measure
- To evaluate the effect of intensive lifestyle modification on insulin sensitivity in men receiving GnRH agonist therapy for prostate cancer.
- timeFrame
- 1 year
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed prostate cancer * Current Hormone therapy with GnRH agonist of 3 months or longer * Overweight or obese (body mass index of 25kg/m2 or greater) * No other conditions that prevent intensive lifestyle intervention Exclusion Criteria: * History of diabetes mellitus requiring drug therapy * Hemoglobin Aic of 7% or greater * Symptomatic metastatic disease * Myocardial infarction within 6 months * Treatment with anabolic agents or metabolic agents known to affect insulin or glucose levels * Disease progression according to PSA Working Group Criteria
References
Publications (0)
Data not yet available
No reference posted for this study.